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Description
The Compliance Suite platform is a versatile and innovative technology solution designed to facilitate the preparation and submission of various regulatory forms, including the Securities and Exchange Commission’s Form N-PORT, Form N-CEN, Form N-MFP, and Form PF, along with other filing obligations such as Annex IV of AIFMD and CFTC, and NFA Form CPO-PQR. Additionally, it offers comprehensive tools for risk management, performance monitoring, and managing pipeline and relationships within the asset management sector. This user-friendly and scalable solution delivers the adaptability needed to navigate today’s fast-paced business, risk, and regulatory environments. The architecture of Compliance Suite allows for customization, enabling the system to be utilized for purposes beyond just regulatory filings. Furthermore, it serves as a data repository for internal risk assessment and investor reporting, while also featuring a customizable dashboard and fund performance charting capabilities to enhance user experience. Ultimately, this platform empowers asset managers to streamline compliance processes and improve operational efficiency.
Description
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
API Access
Has API
API Access
Has API
Integrations
AWS GovCloud
Appway Digital Banking
Cevinio
Duvo.ai
Exponential AI Enso
Microsoft 365
Microsoft Entra ID
OpenText Core Share
Oracle Audience Segmentation
Oracle Digital Assistant
Integrations
AWS GovCloud
Appway Digital Banking
Cevinio
Duvo.ai
Exponential AI Enso
Microsoft 365
Microsoft Entra ID
OpenText Core Share
Oracle Audience Segmentation
Oracle Digital Assistant
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$13,750/year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Deloitte
Founded
1845
Country
United Kingdom
Website
www2.deloitte.com/content/dam/Deloitte/us/Documents/risk/us-risk-financial-technology-compliance-suite.pdf
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Product Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
